TPLC - Total Product Life Cycle

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Device	anesthesia conduction kit
Regulation Description	Anesthesia conduction kit.
Definition	This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product Code	CAZ
Regulation Number	868.5140
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARROW INTERNATIONAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
BECTON DICKINSON AND COMPANY
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU CAINA MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
PAJUNK GMBH MEDIZINTECHNOLOGIE
	SUBSTANTIALLY EQUIVALENT	2
1. K190345 VPC
2. K202699 E-Cath STIM acc. Tsui

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	293	293
Fluid/Blood Leak	250	250
Leak/Splash	118	118
Detachment of Device or Device Component	78	78
Patient-Device Incompatibility	71	71
Lack of Effect	41	41
Disconnection	39	39
Defective Component	37	37
Material Separation	33	33
Material Twisted/Bent	32	32
No Flow	29	29
Adverse Event Without Identified Device or Use Problem	26	26
Packaging Problem	26	26
Material Split, Cut or Torn	26	26
Failure to Advance	25	25
Complete Blockage	25	25
Loose or Intermittent Connection	24	24
Device Markings/Labelling Problem	24	24
Separation Problem	23	23
Difficult to Insert	21	21
Difficult to Remove	21	21
Activation, Positioning or Separation Problem	19	19
Physical Resistance/Sticking	19	19
Contamination /Decontamination Problem	17	17
Device Contamination with Chemical or Other Material	17	17
Output Problem	17	18
Defective Device	16	16
Material Fragmentation	15	15
Obstruction of Flow	14	14
Tear, Rip or Hole in Device Packaging	13	13
Therapeutic or Diagnostic Output Failure	12	12
Infusion or Flow Problem	11	11
Difficult to Advance	11	11
Fracture	11	11
Crack	10	10
Material Puncture/Hole	10	10
Component Missing	10	10
Connection Problem	9	9
Material Too Rigid or Stiff	9	9
Device Dislodged or Dislocated	7	7
Insufficient Flow or Under Infusion	7	7
Mechanical Problem	7	7
Device Damaged Prior to Use	6	6
Appropriate Term/Code Not Available	6	6
Delivered as Unsterile Product	6	6
Use of Device Problem	6	6
Material Integrity Problem	6	6
Failure to Deliver	6	6
Entrapment of Device	6	6
Blocked Connection	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	607	607
No Consequences Or Impact To Patient	338	338
No Known Impact Or Consequence To Patient	141	145
No Patient Involvement	106	106
Foreign Body In Patient	71	71
Insufficient Information	64	64
No Information	35	35
Pain	28	28
Awareness during Anaesthesia	27	27
Device Embedded In Tissue or Plaque	24	24
Cerebrospinal Fluid Leakage	16	16
Inadequate Pain Relief	14	14
Infiltration into Tissue	11	11
Perforation	10	10
Headache, Lumbar Puncture	10	10
Blood Loss	10	10
Needle Stick/Puncture	9	9
Headache	7	7
Numbness	5	5
Therapeutic Effects, Unexpected	4	4
Dyspnea	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	5
Paresthesia	3	3
Discomfort	3	3
No Code Available	3	3
Abscess	3	3
Unspecified Infection	2	2
Chemical Exposure	2	2
Muscle Weakness	2	2
Twitching	2	2
Patient Problem/Medical Problem	2	2
Failure of Implant	2	2
Bradycardia	2	2
Underdose	2	2
Anxiety	2	2
Therapeutic Response, Decreased	2	2
Urinary Tract Infection	1	1
Nervous System Injury	1	1
Low Oxygen Saturation	1	1
Low Blood Pressure/ Hypotension	1	1
Unspecified Vascular Problem	1	1
Loss of consciousness	1	1
High Blood Pressure/ Hypertension	1	1
Neuropathy	1	1
Hypersensitivity/Allergic reaction	1	1
Undesired Nerve Stimulation	1	1
Extravasation	1	1
Muscle/Tendon Damage	1	1
Hyperesthesia	1	1
Tingling	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Arrow International Inc	II	Aug-13-2020
2	Arrow International Inc	II	Feb-14-2020
3	Arrow International Inc	II	Jan-24-2020
4	MEDLINE INDUSTRIES, LP - Northfield	II	Nov-22-2024
5	Smiths Medical ASD Inc.	II	Apr-29-2020